CAndesartan vs LIsinopril Effects on the BRain (CALIBREX)

• ClinicalTrials.gov Identifier: NCT01984164
• Recruitment Status: Completed
• First Posted: November 14, 2013
• Results First Posted: February 21, 2021
• Last Update Posted: February 21, 2021
• Sponsor: Emory University
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Ihab Hajjar, Emory University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Conditions: Hypertension; Mild Cognitive Impairment
• Interventions: Drug: Candesartan; Drug: Lisinopril
• Enrollment: 176

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Candesartan	Lisinopril
Arm/Group Description	To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Candesartan: blinded	To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Lisinopril: Blinded
Period Title: Overall Study
Started	87	89
Completed	77	64
Not Completed	10	25
Reason Not Completed
Withdrawal by Subject	4	3
Adverse Event	5	19
Lost to Follow-up	1	3

Baseline Characteristics

Arm/Group Title		Candesartan	Lisinopril	Total
Arm/Group Description		To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Candesartan: blinded	To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Lisinopril: Blinded	Total of all reporting groups
Overall Number of Baseline Participants		87	89	176
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	87 participants	89 participants	176 participants
		66.1 (8.3)	65.8 (7.2)	65.9 (8.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	87 participants	89 participants	176 participants
	Female	47 54.0%	54 60.7%	101 57.4%
	Male	40 46.0%	35 39.3%	75 42.6%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	87 participants	89 participants	176 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	56 64.4%	57 64.0%	113 64.2%
	White	29 33.3%	31 34.8%	60 34.1%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	2 2.3%	1 1.1%	3 1.7%
Region of Enrollment [1]; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	87 participants	89 participants	176 participants
		87	89	176
		[1] Measure Description: Of 176 eligible participants enrolled and randomized to candesartan or lisinopril, 35 dropped out before study completion (25 from the lisinopril arm and 10 from the candesartan arm). The final sample for the intention-to-treat analysis was 141 individuals, including 77 in the candesartan group and 64 in the lisinopril group.
MoCA score [1]; Mean (Standard Deviation); Unit of measure: Points
	Number Analyzed	87 participants	89 participants	176 participants
		21.4 (3.4)	21.7 (3.5)	21.5 (3.4)
		[1] Measure Description: MoCA is a 30-point scale administered in 10 minutes, is validated in Spanish and is highly sensitive to identify mild vascular-related cognitive dysfunction. MoCA includes assessment of MoCA assesses: Short term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language and orientation to time and place. Scale is 0-30 with higher indicated better cognitive performance.

Outcome Measures

1. Primary Outcome

Title	Executive Function
Description	Executive function will be assessed using Trail Making Test (part B-A). Part A was collected to correct for motor speed and visual-perceptual demands on TMT by subtracting completion time for TMT Part A from completion time for Part B (TMT B - A). TMT Part B-A provides a relatively purer measure of executive functioning. It has a timed scale from 0 sec (min) to 300 secs (max). Along this scale, a lower score is better.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Candesartan	Lisinopril
Arm/Group Description:	To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Candesartan: blinded	To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Lisinopril: Blinded
Overall Number of Participants Analyzed	87	89
Least Squares Mean (Standard Error); Unit of Measure: seconds
	87.23 (5.46)	111.37 (5.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Candesartan, Lisinopril
	Comments	All analyses were conducted using the intention-to-treat principle. Results are provided as adjusted least-square means with SE and effect size (ES) estimates (calculated from mixed model with repeated measures (MMRM) as the adjusted difference in cognitive change between the 2 groups over the study period).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Treatment effect size
	Estimated Value	-13.6
	Confidence Interval	(2-Sided) 95%; -23.6 to -3.7
	Estimation Comments	effect size p-value = 0.008

2. Primary Outcome

Title	NINDS-initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or "EXAMINER" Tool Box.
Description	EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or "EXAMINER" tool box. This test batteryThe battery includes 11 tasks that generate 15 primary variables. Within this set, the EXAMINER includes: working memory, inhibition, set shifting, and fluency. The parts of EXAMINER that were used for this study include: Flanker task (inhibition) which involves responding to a central stimulus while ignoring flanking stimuli that are either compatible or incompatible with the central stimulus; Set-shifting, a measure of mental flexibility; Spatial 1-Back test assesses spatial working memory; Dot Counting test assesses verbal working memory; Verbal Fluency tested using a List Generation test which require the participant to generate words beginning with a specific letter, and category fluency in which the participant generates words from a specified category (e.g., animals, fruits). Higher are reflective of better executive function (-1 to +1)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Candesartan	Lisinopril
Arm/Group Description:	To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Candesartan: blinded	To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Lisinopril: Blinded
Overall Number of Participants Analyzed	87	89
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.07 (0.07)	0.25 (0.07)

3. Secondary Outcome

Title	Memory
Description	To assess episodic memory, the Hopkins Verbal Learning Test-Revised (HVLT-R) will be used. The retention (%) score is calculated by dividing the delayed recall trial by the higher of 3 learning trials. Each trial scores 0 (min) to 12 (max). The HVLT-R retention score is a percentage, and a higher percentage represents a better outcome.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Candesartan	Lisinopril
Arm/Group Description:	To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Candesartan: blinded	To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Lisinopril: Blinded
Overall Number of Participants Analyzed	87	89
Least Squares Mean (Standard Error); Unit of Measure: percentage of retention
	82.71 (3.26)	79.47 (3.39)

4. Secondary Outcome

Title	Language
Description	This will be measured using the Boston Naming Test. BNT is a neuropsychological test used to assess visual confrontation naming and language performance in participants with cognitive decline. Its short 15-item version consists of drawings of objects ranging from common objects to less familiar objects. Scale: 0 (min score) to 15 (max score). For this test, a higher score/response represents a better outcome.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Candesartan	Lisinopril
Arm/Group Description:	To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Candesartan: blinded	To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Lisinopril: Blinded
Overall Number of Participants Analyzed	87	89
Least Squares Mean (Standard Error); Unit of Measure: number of correct responses
	13.42 (0.18)	13.84 (0.18)

5. Secondary Outcome

Title	Attention Measured Using Digit Span Backward
Description	The Digit Span test is a subtest of both the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Memory Scales (WMS). For the digit span backwards, subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in reverse order (backward span). Backward span is an executive task particularly dependent on working memory. The Digit Span backward is scored for backwards performance. Scale: 0 (minimum) to 16 (maximum). A higher score represents a better outcome.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Candesartan	Lisinopril
Arm/Group Description:	To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Candesartan: blinded	To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Lisinopril: Blinded
Overall Number of Participants Analyzed	87	89
Least Squares Mean (Standard Error); Unit of Measure: Number of correct responses
	5.14 (0.25)	5.16 (0.26)

6. Secondary Outcome

Title	White Matter Lesion Volume
Description	White Matter Lesion volume: high-resolution anatomical images are acquired for the measurement of microvascular disease. WMH volumes will be obtained from Fluid attenuated inversion recovery (FLAIR) imaging sequence and reported as total volume (in mm3). Higher values means greater WMH
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 176 randomized participants, 27 did not complete an MRI scan at baseline (15 had metal implants with either pacemaker, stent, or inferior vena cava filter and 12 were claustrophobic). Of 141 participants who returned for their 12-month visit, an additional 8 participants refused to have a follow-up MRI. The final sample with both baseline and 12-month MRI was 104 participants (73.8%), including 51 participants in the candesartan group and 53 participants in the lisinopril group.

Arm/Group Title	Candesartan	Lisinopril
Arm/Group Description:	To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Candesartan: blinded	To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Lisinopril: Blinded
Overall Number of Participants Analyzed	51	53
Least Squares Mean (Standard Error); Unit of Measure: mm^3
	2.68 (1.23)	5.73 (1.22)

7. Secondary Outcome

Title	Cerebral Perfusion
Description	ASL-MRI: Arterial Spin Labeling (ASL) MRI is non-invasive measure of perfusion that does not require contrast, and allows multiple brain regions mapping of perfusion and reserve. ASL-MRI provides measures of cerebral blood flow (CBF). Higher values indicates higher CBF.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 176 randomized participants, 27 did not complete an MRI scan at baseline (15 had metal implants with either pacemaker, stent, or inferior vena cava filter and 12 were claustrophobic). Of 141 participants who returned for their 12-month visit, an additional 8 participants refused to have a follow-up MRI. The final sample with both baseline and 12-month MRI was 104 participants (73.8%), including 51 participants in the candesartan group and 53 participants in the lisinopril group.

Arm/Group Title	Candesartan	Lisinopril
Arm/Group Description:	To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Candesartan: blinded	To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Lisinopril: Blinded
Overall Number of Participants Analyzed	51	53
Least Squares Mean (Standard Error); Unit of Measure: ml/100g/min
	45.48 (1.47)	47.65 (1.08)

8. Secondary Outcome

Title	Attention Measured Using Digit Span Forward
Description	This will be measured using Digit Span Forward. The Digit Span test is a subtest of both the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Memory Scales (WMS). For the digit span forward, subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in the correct order (forward span). Forward span captures attention efficiency and capacity. The Digit Span forward is scored for forwards performance. Scale: 0 (minimum) to 16 (maximum). A higher score represents a better outcome.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Candesartan	Lisinopril
Arm/Group Description:	To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Candesartan: blinded	To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Lisinopril: Blinded
Overall Number of Participants Analyzed	87	89
Least Squares Mean (Standard Error); Unit of Measure: Number of correct responses
	9.67 (0.61)	8.93 (0.66)

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Candesartan		Lisinopril
Arm/Group Description	To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Candesartan: blinded		To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved. Lisinopril: Blinded
All-Cause Mortality
	Candesartan		Lisinopril
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/87 (0.00%)		0/89 (0.00%)
Serious Adverse Events
	Candesartan		Lisinopril
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0.00%)		0/89 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Candesartan		Lisinopril
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	87/87 (100.00%)		89/89 (100.00%)
Blood and lymphatic system disorders
Unusual bleeding or bruising *	0/87 (0.00%)	0	1/89 (1.12%)	1
Cardiac disorders
Palpitation *	4/87 (4.60%)	4	4/89 (4.49%)	4
Gastrointestinal disorders
Flatulence *	0/87 (0.00%)	0	1/89 (1.12%)	1
Loss of appetite *	0/87 (0.00%)	0	1/89 (1.12%)	1
Nausea *	2/87 (2.30%)	2	1/89 (1.12%)	1
General disorders
Headache *	18/87 (20.69%)	18	22/89 (24.72%)	22
Dizziness *	15/87 (17.24%)	15	14/89 (15.73%)	14
Edema *	13/87 (14.94%)	13	12/89 (13.48%)	12
General Pain *	7/87 (8.05%)	7	9/89 (10.11%)	9
Fatigue *	9/87 (10.34%)	9	7/89 (7.87%)	7
Insomnia *	0/87 (0.00%)	0	2/89 (2.25%)	2
Falling *	3/87 (3.45%)	3	1/89 (1.12%)	1
Dry mouth *	1/87 (1.15%)	1	1/89 (1.12%)	1
Sweating *	0/87 (0.00%)	0	1/89 (1.12%)	1
Fainting *	1/87 (1.15%)	1	0/89 (0.00%)	0
Metabolism and nutrition disorders
Low potassium (<3.0) *	2/87 (2.30%)	2	0/89 (0.00%)	0
Musculoskeletal and connective tissue disorders
Leg Cramps *	1/87 (1.15%)	1	2/89 (2.25%)	2
Renal and urinary disorders
Frequent urination *	4/87 (4.60%)	4	3/89 (3.37%)	3
Worsening renal function (serum creatinine >2.5) *	1/87 (1.15%)	1	0/89 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Cough *	7/87 (8.05%)	7	24/89 (26.97%)	24
Nasal/sinus drainage *	1/87 (1.15%)	1	6/89 (6.74%)	6
Runny nose *	2/87 (2.30%)	2	2/89 (2.25%)	2
Shortness of breath *	0/87 (0.00%)	0	1/89 (1.12%)	1
Wheezing *	0/87 (0.00%)	0	1/89 (1.12%)	1
Hoarseness *	1/87 (1.15%)	1	1/89 (1.12%)	1
Sore throat *	1/87 (1.15%)	1	1/89 (1.12%)	1
Skin and subcutaneous tissue disorders
Rash *	8/87 (9.20%)	8	1/89 (1.12%)	1
Vascular disorders
Severe elevation in systolic BP >200 mmHg *	0/87 (0.00%)	0	1/89 (1.12%)	1
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

A limitation of this study is its 1-year study period. Additional limitations include the relatively small sample size, which limited our power to correct for multiple comparisons.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Hajjar
• Organization: Emory University
• Phone: 404-712-2036
• EMail: ihabhajjar@emory.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hajjar I, Okafor M, McDaniel D, Obideen M, Dee E, Shokouhi M, Quyyumi AA, Levey A, Goldstein F. Effects of Candesartan vs Lisinopril on Neurocognitive Function in Older Adults With Executive Mild Cognitive Impairment: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2012252. doi: 10.1001/jamanetworkopen.2020.12252.

• Responsible Party: Ihab Hajjar, Emory University
• ClinicalTrials.gov Identifier: NCT01984164
• Other Study ID Numbers: IRB00070087; R01AG042127 ( U.S. NIH Grant/Contract )
• First Submitted: October 27, 2013
• First Posted: November 14, 2013
• Results First Submitted: December 14, 2020
• Results First Posted: February 21, 2021
• Last Update Posted: February 21, 2021